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Although M9 guidance references important intestinal transporters, i.e., P-gp and BCRP, Caco-2 cell monolayers are limited in M9 to only assessing high permeability of passively transported drugs due to the potential lack of transporter expression

Review Article OPEN ACCESS Madhumitha Rondla 2 , Karthik Muralidharan 1 and Sun-Joo Jang 1,* Received: Revised: Accepted: Published online: Author information Citation: Mathialagan K, Rondla M, Muralidharan K, Jang SJ

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Novo and Mylan filed their settlement agreements with the board, and asked that the documents be treated as business confidential information accessible only to the PTAB because they contain highly sensitive business confidential information that would substantially harm their business interests if publicly disclosed. The two companies asked to be notified if others request access to the settlement agreements pursuant to a statute that provides for such agreements to be made available to federal government agencies upon written request